Monitoring Neonatal Resuscitation Trial (MONITOR)

A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth

This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.

Study Overview

• Status: Completed
• Conditions: Resuscitation; Positive-Pressure Respiration; Neonatal Prematurity
• Intervention / Treatment: Device: New Life Box Respiratory Function Monitor

Detailed Description

Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.

The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.

The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.

The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
• Receive positive pressure ventilation during delivery room resuscitation

Exclusion Criteria:

• Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
• RFM not available during resuscitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFM visible; During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.	Device: New Life Box Respiratory Function Monitor; The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.
No Intervention: RFM masked; During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg	To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.	the first 15 minutes of resuscitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life	Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life	approximately first 5 minutes of life
Heart Rate in the First 10 Minutes of Life	Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life	between 3 and 10 minutes of life
Percentage of Time With Mask Leak During PPV Ventilation	Percentage of time with significant mask leak (defined as > 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.	approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Airway Obstruction	Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte <1 mL/kg, with minimal mask leak (<25%) during an inflation and flattening of the flow waves.	approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Inadequate Tidal Volume	Percentage of PPV inflations with inadequate tidal volume defined as Vte <4 ml/kg in the first 15 minutes of resuscitation.	approximately first 15 minutes of resuscitation
Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life	Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life	Between 3 and 10 minutes of life
Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life	Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life	between 3 and 10 minutes of life
Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life	Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.	approximately first 10 minutes of life
Number of Participants Receiving Endotracheal Intubation in the Delivery Room	Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU	from time of birth to admission to NICU
Number of Participants Requiring Inotropes for Circulatory Support	Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth	within the first 3 days after birth
Number of Participants With Pneumothorax	Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention	in the first 72 hours after birth
Number of Participants With Pulmonary Interstitial Emphysema	Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention	in the first 72 hours of life
Number of Participants With Abnormal Cranial Ultrasound Findings	Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months	through study completion, an average of 4 months
Duration of Endotracheal Ventilation	Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months	days through study completion, an average of 4 months
Duration of Non-invasive Ventilation	Duration of non-invasive ventilation, days through study completion, an average of 4 months	days through study completion, an average of 4 months
Duration of Supplemental Oxygen Therapy	Duration of supplemental oxygen therapy days through study completion, an average of 4 months	days through study completion, an average of 4 months
Total Duration of Assisted Ventilation	Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months	through study completion, an average of 4 months
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia	Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support	at 36 weeks corrected gestational age
Neonatal Mortality	Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first	from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
Composite Outcome of Death or BPD	Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age	BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
Number of Participants With Retinopathy of Prematurity Requiring Treatment	Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months	before hospital discharge, an average of 4 months
Number of Participants With a Diagnosis of Necrotizing Enterocolitis	Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months	before hospital discharge, an average of 4 months
Number of Participants Requiring Fluid Boluses for Circulatory Support	Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life	within the first 3 days of life
Number of Participants With Endotracheal Intubation in the NICU	Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life	in the first 24 hours of life
Neonatal Mortality in the Delivery Room	Neonatal Mortality in the delivery room from time of birth until transfer to NICU	from time of birth until transfer to NICU

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Karolinska University Hospital; Leiden University Medical Center; Vittore Buzzi Children's Hospital; Royal Women's Hospital in Melbourne, Australia; Maternal & Children's University Hospital, Valencia, Spain
• Investigators: Principal Investigator: Arjan te Pas, MD, Leiden University Medical Center

Publications and helpful links

General Publications

• Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.
• Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.
• van Zanten HA, Kuypers KLAM, van Zwet EW, van Vonderen JJ, Kamlin COF, Springer L, Lista G, Cavigioli F, Vento M, Nunez-Ramiro A, Oberthuer A, Kribs A, Kuester H, Horn S, Weinberg DD, Foglia EE, Morley CJ, Davis PG, Te Pas AB. A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth. Resuscitation. 2021 Oct;167:317-325. doi: 10.1016/j.resuscitation.2021.07.012. Epub 2021 Jul 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Resuscitation; Respiratory Function Monitor; Positive-Pressure Ventilation; Neonatal Prematurity
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 826695; NTR4104 (Registry Identifier: Netherlands Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No